Clinical Trials /

Safety and Efficacy of AIV001 on Low Risk Basal Cell Carcinoma



To evaluate safety and efficacy of AIV001 treatment on low-risk basal cell carcinoma.

Related Conditions:
  • Basal Cell Carcinoma
Recruiting Status:



Phase 1/Phase 2

Trial Eligibility



  • Brief Title: Safety and Efficacy of AIV001 on Low Risk Basal Cell Carcinoma
  • Official Title: An Exploratory Study to Evaluate the Safety and Efficacy of AIV001 Intradermally Administered in Subjects With Biopsy-confirmed Basal Cell Carcinoma

Clinical Trial IDs

  • ORG STUDY ID: AIV001-C01
  • NCT ID: NCT04470726


  • Superficial Basal Cell Carcinoma
  • Nodular Basal Cell Carcinoma


AIV001AIV001 Treatment Dose 1


To evaluate safety and efficacy of AIV001 treatment on low-risk basal cell carcinoma.

Trial Arms

AIV001 Treatment Dose 1ExperimentalIntradermal/intratumoral, Dose 1
  • AIV001
AIV001 Treatment Dose 2ExperimentalIntradermal/intratumoral, Dose 2
  • AIV001
AIV001 Treatment Dose 3ExperimentalIntradermal/intratumoral, Dose 3
  • AIV001

Eligibility Criteria

        Inclusion Criteria:

          1. Male or female, aged 18 to 80 years, inclusive

          2. No clinically relevant abnormalities identified by a detailed medical history and
             vital signs

          3. Presence of a histologically confirmed low risk BCC lesion, with well-defined borders,
             and with a largest diameter measure before biopsy of 5 mm to 20 mm, located on arms or

          4. Histological diagnosis of the target lesion must have been conducted 5 to 30 days
             prior to Day 1

          5. No other dermatological disease within 50 mm of the target lesion at Day 1

          6. No prior or concurrent treatment of the target lesion (including radiation therapy)

          7. Willing to undergo surgical excision approximately 63 days after first treatment.

        Exclusion Criteria:

          1. History or presence of systemic cancer

          2. Prior radiation treatment at the lesion site or anywhere else on the body within the
             past 20 years

          3. Concurrent disease or treatment that suppresses the immune system (eg, previous organ
             transplant history, etc.)

          4. Clinically relevant cardiovascular, endocrine, hepatic, neurologic, renal, or other
             major systemic disease that could complicate execution of the protocol or
             interpretation of the study results.

          5. History of thrombotic events, hemorrhagic events, and gastrointestinal perforation and

          6. History of recurrence or presence of any other tumor subtype in the target lesion

          7. Concurrent presence of a malignant lesion within 100 mm of the target lesion that will
             require treatment during the study

          8. Current enrollment in any other investigational drug or device study within 60 days of
             Day 1 of this study

          9. Evidence of dermatological disease or confounding dermatological condition that would
             hinder carrying out the study or interpreting the results (eg, atopic dermatitis,
             eczema, psoriasis, xeroderma pigmentosa, etc.)
Maximum Eligible Age:80 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Adverse events
Time Frame:Approximately 84 days
Safety Issue:
Description:Incidence of adverse events

Secondary Outcome Measures

Measure:Clearance of basal cell carcinoma
Time Frame:Approximately 63 days
Safety Issue:
Description:Number of participants cleared of basal cell carcinoma within study duration


Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:AiViva BioPharma, Inc.

Trial Keywords

  • Nonmelanoma Skin Cancer
  • Keratinocyte Carcinoma
  • NMSC
  • BCC

Last Updated

January 13, 2021